Pelvic Fixation and Fusion During Multilevel Spinal Surgery (NCT05640908) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
United States200 participantsStarted 2023-06-05
Plain-language summary
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 18 years of age at screening.
. Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite
. Patient is willing and able to provide written informed consent
Exclusion criteria
. Any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s)
. Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation
. Known allergy to titanium or titanium alloys
. Current local or systemic infection that raises the risk of surgery
. Currently pregnant or planning pregnancy in the next 2 years
. Known or suspected active drug or alcohol abuse, including opioids
. Patient is a prisoner or ward of the state
. Patient is enrolled in an investigational clinical trial related to the spine
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative incidence of serious adverse events probably or definitely related to GRANITE
Timeframe: 2 years
2
Postoperative incidence of SI joint pain in subject without SI joint pain at baseline
Timeframe: 2 years
3
Postoperative incidence of L5-S1 pseudoarthrosis
Timeframe: 2 years
4
Postoperative incidence of pelvic construct failure
Timeframe: 2 years
5
Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)